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EC number: 947-979-9 | CAS number: -
For all of the four substances within the amphoteric, glycinate substance group there are available acute oral toxicity data. The endpoint data covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the group. The studies have been performed under GLP and according to current OECD 401 guideline. In all of the studies the maximum dose tested was 5000 mg/kg bw on the technical products. As the technical products consists of approximately 40 % active ingredient, it is estimated that doses corresponding to 2000 mg a.i./kg bw were tested. The LD50 values are therefore considered to be > 2000 mg a.i./kg bw and no classification for acute oral toxicity is therefore required according to CLP.
No toxic effects were seen within this dose range for any of the tested substances. This is also in line with the QSAR predictions available on this group of structures. ACD ToxSuite indicates LD50 values > 2000 mg/kg bw for all of the four substances. Within a category of structures the acute toxicity is decreased for longer chain lengths, but increased for alkyl chains with higher unsaturation. This is also predicted by the QSAR models.
An acute oral limit test was performed under GLP and according to OECD 401. Following overnight fasting a group of five male and five female rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects of treatment were observed throughout the duration of the study and no. abnormalities were detected at necropsy. The results of this study indicate that the technical product consisting of 40% Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) in aqueous solution has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000mg/kg bodyweight.
Based on the composition of the technical product, the dose level tested is considered to be 2000 mg active ingredient/kg bw based on Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1). Under the conditions of this study the LD50 > 2000 mg a.i./kg bw. NOTE: PH WAS NEUTRALISED.
Based on molecular profiling, dermal absorption is expected to be (much) lower than oral. Taking together the low acute oral toxicity profile within the amphoteric, glycinate group of substances, and the expected low dermal absorption, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies.
Acute inhalation toxicity
The measured vapour pressure data on the freeze-dried triamine based amphoteric, glycinate with the shortest alkyl chain (Amines, N-(3-aminopropyl)-N’-C12-18-alkyltrimethylenedi-, N-(carboxymethyl)derivs., sodium salts with CAS number 2060541-51-5) is available and used for the entire group. This value is low and also considered to be a worst case compared to the vapour pressure for the aqueous solutions of the substances which are manufactured, used and put on the marked. Taking together the low acute oral toxicity profile within this group of substances and the low vapour pressure of the aqueous technical product in combination with the low potential for aerosol formation, it is not considered justified from an animal well-fare perspective to perform any additional acute dose toxicity studies.
The conclusion from the available studies within the group of substances, is that Sodium oleylamphopolycarboxyglycinate, (1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-[(9Z)-9-octadecen-1-ylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts with CAS no 2060541-49-1) and the other three substances within the amphoteric, glycinate substane group, are not to be classified for acute toxicity according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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